Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention

Geoffrey C. Garth

Status: Unknown

Conditions: Chronic Opioid Use; Chronic Lower Back Pain

Treatments: Device: In-elastic lumbar brace; Device: Elastic abdominal binder

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02241824

MIRB# 1273

Details and patient eligibility

About

Rationale

• Statement of the Problem. Low back pain is a significant societal problem in the United States, affecting approximately one-fourth of all Americans at any given time. Non-pharmacological therapies have not been well studied although preliminary evidence shows the utilization of bracing may be beneficial in reducing pain and medication usage.
• Hypotheses or Key Question. The investigators hypothesize that the use of an inelastic lumbar brace may decrease opioid use in chronic low back pain patients on a stable opioid regimen. The investigators propose to conduct a randomized controlled study to test our hypothesis.
• Specific Objectives.

AIM 1: To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen in a three armed trial, after an intervention of an in-elastic lumbar brace, elastic abdominal binder (standard care), and no brace (control).

AIM 2: To evaluate changes in secondary endpoints such as pain intensity, quality of life, and functional capacity.

Long Term aims: To decrease patient's chronic pain level, improve overall daily function, decrease overall opioid intake and improve quality of life.

Full description

Background and Significance

Low back pain (LBP) is a common problem in our society with potential for significant morbidity and mortality. One of the treatments for LBP, opioid therapy, has been increasingly utilized for noncancerous pain,1 and has a 4.2% prevalence in the United States alone.2 The long term use of opioids carries its own risk for adverse events and risk of addiction.3 Thus, with the lack of evidence based research for treatments of LBP, the rising epidemiology of LBP in the US, the rise in cost of medical care, along with the potential risks of opioid therapy, our attention needs to be drawn to find more affordable alternatives.

Our study proposes to evaluate whether an inelastic lumbar brace will reduce chronic opioid use in the chronic low back pain population. The specific aims of this project are to perform a pilot study to assess the feasibility of this project and plan for a larger randomized controlled trial. Additional long-term goals of this study are to assess the effect of an inelastic lumbar brace in a chronic LBP population, and if there is a significant decrease in opioid use and subsequent control or reduction of pain. Secondary endpoints will note improvement in functional outcomes and other quality of life measures. The findings of this preliminary study conducted at the VA facility will provide data to perform a large multi-center randomized controlled trial and prepare for a NIH proposal to study other benefits of inelastic lumbar bracing.

(3) Work Accomplished

(a) New submissions: Preliminary studies have not been conducted yet. (b) Submissions Following Pilot Studies: Sponsored new study

(4) Work Proposed This trial will be a prospective randomized three armed trial of an in-elastic lumbar brace group (BG), elastic abdominal binder (EG), and a control group [no brace] (CG) in the treatment of chronic low back pain patients are prescribed chronic opioid medications with follow-up monitoring up to 12 months.

Enrollment: 36 estimated patients

Sex: Male

Ages: 20 to 72 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must satisfy diagnostic criteria for lumbar back pain

• Evidence of lumbar back pain base upon one or more of the following:

  • Lumbar back pain episodes lasting greater than 3 months
  • Has received treatment for recurring nonspecific low back pain
  • Treatment with 3-6 months of stable opioid use.

• Men or women age greater than or equal to 20 years

• Fluency in English

Exclusion criteria

• Treatment risk factors including one or more of the following:

  • Unstable or symptomatic cardiac complaints
  • Unstable or symptomatic respiratory complaints
  • Unable to reliably comprehend the protocol or reliably record data

• Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.

• Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.

• No significant alcohol use (7 or fewer drinks per week).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Elastic abdominal binder

Active Comparator group

Description:

To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an elastic abdominal binder.

Treatment:

Device: Elastic abdominal binder

No brace

No Intervention group

Description:

To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen with no brace (control).

In-elastic lumbar brace

Experimental group

Description:

To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an in-elastic lumbar brace.

Treatment:

Device: In-elastic lumbar brace